A Phase 2 interventional study of Common bean baked snack and Cooked beans in Overweight and Healthy, sponsored by Centro Universitario de Ciencias de la Salud, Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Centro Universitario de Ciencias de la Salud, Mexico · Phase 2, Interventional, and Treatment
Introduction: Overweight and obesity are associated with an unbalanced energy intake caused by unhealthy dietary habits, including a constant consumption of energy-dense foods, saturated and trans fats, refined sugars, along with a deficient protein and dietary fiber intake. Pulse consumption has been demonstrated to improve long-term body weight management. Despite these benefits, in several regions, the consumption of pulses does not meet the local recommendations. Consequently, pulse research has increased widely in order to provide food alternatives reformulated with pulses to promote their consumption.
Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) and cooked beans increases satiety, reduces energy intake and produce a low glycemic response in people with overweight and normal weight.
Objectives: Evaluate the acute effect of a common bean baked snack and cooked bean consumption on subjective satiety and energy intake in people with overweight and normal weight.
Material and Methods: Randomized crossover clinical trial, 18 subjects with normal weight and 18 subjects with overweight, 18-50 years old, consumption of 40 g of common bean baked snack, cooked beans and white bread (control). Subjective satiety, energy intake and glycemic response.
Additionally, the glycemic index will be determined under the International Organization for Standardization (ISO) 26642:2010.
10 subjects with normal weight or overweight, 18-50 years old, consumption of 54 g of common bean baked snack and 25 g of anhydrous glucose.
3,771 studies on the registry are indexed under Overweight; 861 are open to participants now.
This study's enrollment of 18 is below the median of 73 across 3,267 interventional studies indexed under Overweight.
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Exclusion Criteria:
People with normal weight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Other: Common bean baked snack · Other: Cooked beans · Other: White bread
People with overweight will consume 40 g of common bean baked snack, cooked beans or white bread for a single occasion.
Other: Common bean baked snack · Other: Cooked beans · Other: White bread
Determination of glycemic index under the ISO 26642:2010.
Other: Anhydrous glucose (first session) (for glycemic index determination) · Other: Anhydrous glucose (second session) (for glycemic index determination) · Other: Common bean baked snack (for glycemic index determination)
Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.
Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.
Participants with normal weight (n=18) and with overweight (n=18) will attend the institute after 10-14 h fasting. Initially, they are going to complete a physical activity questionnaire, and the first visual analog scale (VAS) of subjective satiety questionnaire followed by a finger-prick blood sample. Immediately, they will be instructed to consume 40 g of the preload (common bean baked snack, cooked beans or white bread) along with 100 mL of water within 10 min. The VAS and blood glucose will be measured every 15 min after starting to eat the test food. Another VAS will be used to assess the palatability of the preload products. After 45 min, an ad libitum meal consisting of freshly prepared sandwiches and 250 mL of water will be served in a single portion. Finally, the VAS of subjective satiety is going to be assessed again.
Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume a reference glucose solution containing 25 g of anhydrous glucose per 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to drink the reference glucose solution. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.
Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume 54 g of common bean baked snack with 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to eat the test food. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.
Participants with normal weight or overweight (n=10) will attend the institute after 10-14 h fasting. At first, two baseline finger-prick blood samples will be collected with 5 min between the samples. Then, they are going to consume 54 g of common bean baked snack with 250 mL of water within 12-15 min. Later, finger-prick blood samples will be taken at 15, 30, 45, 60, 90 and 120 min after starting to eat the test food. Areas under the glucose response curves (iAUC) will be calculated using the trapezoidal rule, ignoring the areas below the fasting value.
Change in Subjective Satiety
Subjective satiety will be measured using a 100-mm visual analogue scale \[0 mm (not at all) - 100 mm (completely)\] at 0, 15, 30 and 45 minutes after ingestion of the test meals. The scale comprises different perceptions of satiety including: hunger, fullness, prospective food intake, and thirst.
Time frame: 45 minutes period, every 15 min after ingestion of the test meal.
Ad libitum energy intake (kcal)
Participants will consume sandwiches until they feel comfortably satisfied. The calories consumed will be calculated from the difference in weight of the initial and final portions of the sandwiches, using the nutritional information on the label of the package of each ingredient.
Time frame: 45 minutes after ingestion of the test meal.
0-45 minutes Glycemic response
Capillary blood glucose (mg/dL)
Time frame: 0, 15, 30 and 45 minutes after ingestion of the test meal.
0-120 minutes Glycemic response
Capillary blood glucose (mg/dL)
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes after ingestion of the test meal.
Plan to share: No — Non-shareable data.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Centro Universitario de Ciencias de la Salud, Mexico